[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Notices]
[Page 45661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18782]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1051]
Modified Risk Tobacco Product Applications: Applications for 10
Products Submitted by Swedish Match North America Inc.; Reopening of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening the period
for public comment on modified risk tobacco product applications
(MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco
products and announcing the availability for public comment of
amendments to the MRTPAs. The notice of availability for the
originally-filed applications appeared in the Federal Register of
August 27, 2014 (79 FR 51183). In that notice, FDA requested comments
on the 10 originally-filed MRTPAs that are posted on http://www.regulations.gov and FDA's Web site. The comment period on these
originally-filed applications closed on February 23, 2015. FDA is
reopening the comment period to seek comment specifically on amendments
made to the originally-filed MRTPAs submitted by Swedish Match North
America Inc.
DATES: Submit either electronic or written comments on the amendments
by August 31, 2015.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Identify comments with Docket Number FDA-2014-N-
1051.
FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993,
1-877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 27, 2014 (79 FR 51183), FDA
published a notice of availability of MRTPAs submitted by Swedish Match
North America Inc. for 10 tobacco products and gave the public 180 days
to comment on the applications.
FDA is required by section 911(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 387k(e)) to make an MRTPA
available to the public (except for matters in the application that are
trade secrets or otherwise confidential commercial information) and to
request comments by interested persons on the information contained in
the application and on the label, labeling, and advertising
accompanying the application. The determination of whether an order is
appropriate under section 911 of the FD&C Act is based on the
scientific information submitted by the applicant as well as the
scientific evidence and other information that is made available to the
Agency, including through public comments.
FDA has received and accepted a number of amendments to Swedish
Match North America Inc.'s 10 originally-filed MRTPAs and is making
these amendments available (except for matters in the amendments that
are trade secrets or otherwise confidential commercial information) for
public comment. FDA is reopening the period for public comment so that
the public has the opportunity to review and comment on these
amendments.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Persons with access to the Internet may obtain the document at
either http://www.accessdata.fda.gov/Static/widgets/tobacco/SMNA_MRTPA_FDA-2014-N-1051.html or http://www.regulations.gov.
Dated: July 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18782 Filed 7-30-15; 8:45 am]
BILLING CODE 4164-01-P